Recruiting

Observational Study

Sponsor:

Boston Children's Hospital

Code:

NCT04103281

Conditions

Sepsis

Eligibility Criteria

Sex: All

Age: 2 - 50

Healthy Volunteers: Not accepted

Interventions

Sepsis

Study Details

Brief summary:

In this research study we want to learn more about the characteristics of neutrophils that are present in the blood and secretions from a breathing tube of patients with sepsis. Sepsis is a severe type of infection, affecting various parts of the body. Neutrophils are a type of white blood cell that are part of the body's immune system. Even though neutrophils are important in getting rid of germs, they also may be harmful to parts of the body by causing injury in the lungs in patients with sepsis. Neutrophils can change their character in sepsis. Because of this, it is important for doctors to know what kind of neutrophils are in the blood and secretions from the breathing tube of patients with sepsis so that they can work to develop therapies to prevent these cells from being harmful.

Conditions

Sepsis

Study ID

NCT04103281

Start date

Sep 1, 2020

Status verified date

Mar, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Jun 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 50

Healthy Volunteers: Not accepted

Case Inclusion Criteria:

  • sepsis patient in the ICU with a breathing tube

Control Inclusion Criteria:

  • scheduled for an elective surgical procedure and need preoperative blood draw or will have an intravenous catheter placed for the purpose of their surgical procedure
  • Plan to have endotracheal tube for planned procedures.

Exclusion Criteria:

  • On chronic immunosuppressive drugs such as chronic corticosteroid use, or preexisting immunodeficiency diseases (oncology patients, patients with transplantation)

Study Design

Enrollment

75 participants

Anticipated

Interventions and Outcome Measures

Arms

Sepsis Patients

Control Patients

Interventions

Sepsis

Sepsis patients in the ICU with a breathing tube

Primary outcome measure

  • Neutrophil characteristics [ Time Frame: One day ]

Central Contacts and Locations

Central contacts

Koichi Yuki, MD

617-355-6225koichi.yuki@childrens.harvard.edu

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Koichi Yuki, MD

617-355-6225koichi.yuki@childrens.harvard.edu

More Information

Sponsor

Boston Children's Hospital

Last update posted

Mar 17, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2026-03-17.